Senior Quality Engineer, Risk Management - Pleasanton

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Leading an active lifestyle is important to the many people we serve. In Abbott's Heart Failure division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

We are seeking an experienced, high caliber Risk Management Senior Engineer . Working within broad objectives, this individual is responsible for ensuring that risk management is effectively implemented throughout the product life cycle. This position provides oversight and guidance for application of Risk Management principles, ensuring that Risk Management requirements are built into the quality system processes and procedures and execution of risk management decisions and activities. The ideal candidate has significant experience in creating new Risk Management documents and revising existing risk-related documents as part of post-production activities.

WHAT YOU'LL DO

• The Risk Senior Quality Engineer works with cross functional teams including regulatory, design assurance, operations quality, and the product performance group to determine Risk Management methods, techniques, and evaluation criteria for medical devices.
• May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• May be responsible for creating risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
• Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD/MDR requirements and solid understanding of the application of ISO 13485/14971
• Perform and guide risk management activities to drive collaborative discussions on appropriate mitigation strategies.
• Conducts special analyses and projects as required.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Maintains risk documentation and establishes procedures that affect department.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• A Bachelor's degree in an applicable engineering discipline with 5+ plus years of progressively more responsible work experience in quality assurance and design related to medical devices, preferably in electro-mechanical and implantable medical devices (class III and IV).
• A minimum of 5 years' experience of Risk Management in the Medical Device or Pharmaceutical Industry, preferably focused on complaint management and Health Hazard Assessments for on-market (or distributed) product.
• Strategic thinking in the inter-relationship between product and user-focused risk management and device design and development.
• Experienced in ISO, EU and FDA regulations, standards and guidance as applicable to risk management and device design.
• Appropriate Science or Engineering Degree.
• Excellent verbal and written communicator; clear and concise in communications with internal and external partners.
• Desired: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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